Ginkgo Biloba

Ginkgo Biloba

PEP Topic 
Cognitive Impairment
Description 

Ginkgo biloba is an extract from the leaves of the ginkgo biloba tree. It is an herbal medicine that has been used for multiple conditions and is generally well tolerated, but case reports suggest it should be used with caution in patients with blood clotting disorders and those on anticoagulants because gingko leaves are believed to contain compounds that thin blood. Gingko biloba has been examined for its effect on cognitive impairment in individuals with cancer.

Wong, C. (2012). Gingko—What you need to know. Retrieved April 1, 2013, from http://altmedicine.about.com/cs/herbsvitaminsek/a/Ginkgo.htm

Effectiveness Unlikely

Research Evidence Summaries

Attia, A., Rapp, S.R., Case, L.D., D'Agostino, R., Lesser, G., Naughton, M., . . . Shaw, E.G. (2012). Phase II study of Ginkgo biloba in irradiated brain tumor patients: Effect on cognitive function, quality of life, and mood. Journal of Neuro-Oncology, 109, 357–363.

doi:10.1007/s11060-012-0901-9
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Study Purpose:

To test the hypothesis that ginkgo biloba may be helpful for radiation-induced cognitive impairment

Intervention Characteristics/Basic Study Process:

120 mg ginkgo biloba was given for 24 weeks and then discontinued for 6 weeks as a washout period. Tests were administered at baseline, 12 weeks, 24 weeks, and 30 weeks after the initial evaluation.

Sample Characteristics:

  • The study reported on a sample of 34 patients with a median age of 47 years (range 22–82).
  • Participants were 32% male and 68% female.
  • Cognitive impairment and depressed mood were present in the sample at baseline.
  • All participants had brain irradiation six or more months prior to study entry and no evidence of disease progression.

Setting:

  • Single site
  • Outpatient    
  • North Carolina

Phase of Care and Clinical Applications:

Phases of Care: Late effects and survivorship

Study Design:

An open label phase II study design was used.

Measurement Instruments/Methods:

  • Mini mental state exam
  • Trail Making Test parts A and B
  • Digit Span Test
  • Revised Rey-Osterrieth Complex Figure Test
  • Verbal fluency (FAS) test
  • California Verbal Learning Test II
  • FACT-Brain
  • Profile of Mood States (POMS)

Results:

Trail Making Test (TMT) results improved significantly from baseline to 24 weeks; however, TMT-Part B continued to improve significantly from week 24 to week 30 after ginkgo was stopped. It is unclear if changes seen demonstrate improvement with treatment or learning effect. Scores for immediate and delayed recall on the Rey-Osterreith Figure were better (p < 0.0002), but these were not measured and reported at 30 weeks. There were no other changes in mental function scores. POMS scores improved for overall mood for the first 24 weeks and then began to decline. By 24 and 30 weeks, only 19 patients remained in the study. Most common toxicities reported were cognitive issues and memory problems. Five patients (16%) discontinued treatment because of gastrointestinal symptoms. One patient discontinued treatment because of intracranial bleed in one patient. Another five patients (16%) discontinued treatment because of no perceived benefit.

Conclusions:

Findings from the study do not provide clear support for the effectiveness of gingko biloba on cognitive impairment caused by brain irradiation.

Limitations:

  • The study had a small sample size with less than 30 participants.
  • A risk of bias was possible because there was no control group, no blinding, and no random assignment.
  • Findings were not generalizable.
  • Subject withdrawals were greater than or equal to 10% of participants.
  • There was a potential testing effect in the study.

Nursing Implications:

Findings do not support effectiveness of gingko biloba to improve cognitive function in patients who have impairment associated with brain radiation.

Barton, D.L., Burger, K., Novotny, P.J., Fitch, T. R., Kohli, S., Soori, G., . . . Loprinzi, C.L. (2013). The use of ginkgo biloba for the prevention of chemotherapy-related cognitive dysfunction in women receiving adjuvant treatment for breast cancer, N00C9. Supportive Care in Cancer, 21, 1185–1192.

DOI: 10.1007/s00520-012-1647-9
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Study Purpose:

Evaluate ginkgo biloba for the prevention of cognitive decline associated with adjuvant treatment for breast cancer

Intervention Characteristics/Basic Study Process:

Patients were randomized to receive 60 mg of ginkgo biloba or a matching placebo twice a day starting before the second cycle of thermotherapy and continuing throughout treatment and 1 month beyond chemotherapy completion. Participants were stratified by type of chemotherapy, age, menopausal status, and lymph node involvement. Data were collected at baseline before the first or second chemotherapy cycle, during chemotherapy, at the first visit after chemotherapy (1 month), and at 6, 12, 18, and 24 months post-chemotherapy.

Sample Characteristics:

  • A total of 210 participants were enrolled in the study.
  • The median age was 50 years.
  • The sample was 100% female.
  • All participants had newly diagnosed breast cancer and were chemotherapy naïve. 
  • All were receiving adjuvant chemotherapy. About 80% were receiving doxorubicin/cyclophosphamide with or without taxanes.
  • 42% of the women were post-menopausal. 
  • 94% of the women were Caucasian.

Setting:

  • Multi-site  
  • Outpatient 
  • 23 institutions in the United States

Phase of Care and Clinical Applications:

Participants were receiving active antitumor treatment.

Study Design:

Double-blind, randomized, placebo-controlled study

Measurement Instruments/Methods:

  • High-Sensitivity Cognitive Screen (HSCS)
  • Profile of Mood States (POMS)
  • Cognitive subscale of the Perceived Health Scale (PHS)
  • Common Terminology Criteria for Adverse Events (CTCAE) grading of adverse events
  • Trail Making Test (TMT) A and B

Results:

No significant differences were seen between groups over 24 months in any study measures. All cognitive test scores improved from baseline to the first chemotherapy follow-up and then stabilized.

Conclusions:

The study does not support the use of ginkgo biloba for prevention of cognitive impairment resulting from chemotherapy treatment in women with breast cancer.

Limitations:

  • A risk of bias existed because of the very homogenous sample.
  • The measurement validity and reliability was questionable because use of the same cognitive measures repeatedly could have resulted in improvement from practice effects.

Nursing Implications:

Findings do not support the use of ginkgo biloba to prevent cognitive changes resulting from chemotherapy in patients with breast cancer.


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